Union européenne - maltais - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - emoglobinurja, paroxysmal - immunosuppressanti selettivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Union européenne - maltais - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva huwa indikat għall-kura ofadult u f'pazjenti pedjatriċi li jkunu għadhom kif ġew dijanjostikati-kromosoma ta ' filadelfja (bcr‑abl) positive (ph+) lewkimja kronika tal-majelojd (cml) li għalihom trapjant tal-mudullun ma jkunx meqjus bħala l-ewwel linja tal-kura. pazjenti adulti u pedjatriċi b'ph+ cml fil-fażi kronika wara l-falliment ta ' l-interferon‑alpha-terapija, jew fil-fażi aċċelerata jew blast crisis. pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati philadelphia chromosome positive li għandhom lewkimja limfoblastika akuta (ph+ all) integrata b'kimoterapija. pazjenti adulti b'all rikadut jew refrattarju ph+ all bħala monoterapija. pazjenti adulti b'mard majelodisplastiku/majeloproliferattiv (mds/mpd) assoċjat ma ' plejtlits-riċettur tal-fattur tat-tkabbir derivat (pdgfr) ġeni mill-ġdid l-arranġamenti. pazjenti adulti b'avvanzati sindrome ipereżinofiliku (hes) u/jew lewkimja kronika eosinofilika (cel) b'fip1l1-pdgfra arranġament mill-ġdid. l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Union européenne - maltais - EMA (European Medicines Agency)

extrovis eu ltd. - sugammadex sodium - imblokk neuromuskolari - il-prodotti terapewtiċi l-oħra kollha - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Union européenne - maltais - EMA (European Medicines Agency)

pfizer europe ma eeig - bosutinib (bħala monoidrat) - lewkimja, myeloid - antineoplastic agents, protein kinase inhibitors - bosulif huwa indikat għat-trattament ta ' pazjenti adulti:għadhom kif ġew dijanjostikati fażi l-kronika (pk) philadelphia chromosome pożittivi għall-lewkimja tal-mudullun kronika (ph+ cml). cp, fil-fażi aċċelerata (ap), u blast phase (bp) ph+ cml li kienu kkurati qabel b'wieħed jew aktar ta 'tyrosine kinase(i) [tki(i)] u li għalihom imatinib, nilotinib u l-dasatinib ma huma kkunsidrati għażliet ta' trattament adattati.

Union européenne - maltais - EMA (European Medicines Agency)

accord healthcare s.l.u. - caspofungin acetate - candidiasis; aspergillosis - antimikotiċi għal użu sistemiku - trattament ta ' kandidjasi invażiva f'pazjenti adulti jew pedjatriċi. trattament ta 'asperġillożi invażiva f'pazjenti adulti jew pedjatriċi li huma refrattorji jew intolleranti għal amphotericin b, formulazzjonijiet lipidi ta' amphotericin b u/jew itraconazole. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. it-terapija empirika għal infezzjonijiet fungali preżunti (bħal candida jew aspergillus) f'bid-deni, newtropeniċi febbri adulti jew pazjenti pedjatriċi.

Union européenne - maltais - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - aġenti antineoplastiċi - erbitux hu indikat għall-kura ta 'pazjenti bil-riċettur tal-fattur tat-tkabbir epidermali (egfr) li jesprimu, ras tat-tip selvaġġ kanċer metastatiku tal-kolorektum:flimkien ma' irinotecan-kimoterapija bbażata fuq;fl-ewwel linja f'kombinazzjoni ma ' folfox;bħala sustanza waħidha f'pazjenti li jkunu fallew oxaliplatin u irinotecan bbażata fuq it-terapija, u li huma intolleranti għal irinotecan. għad-dettalji, ara t-taqsima 5. erbitux hu indikat għall-kura ta 'pazjenti b'kanċer taċ-ċelluli skwamużi tal-ras u l-għonq:f'kombinazzjoni ma' terapija bir-raġġi għal mard li jkun infirex lokalment;flimkien ma ' kimoterapija bbażata fuq platinum rikorrenti u/jew metastatika tal-marda.

Union européenne - maltais - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - follitropin beta - infertility; hypogonadism - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - fil-mara:fertavid huwa indikat għall-kura ta 'nisa infertilità fis-sitwazzjonijiet kliniċi li ġejjin:meta ma jkunx hemm ovulazzjoni (inkluż mard poliċistiku fl-ovarji, pcod) f'nisa li ġew jirrispondux għall-kura bi clomifene citratecontrolled stimulazzjoni eċċessiva tal-ovarji sabiex tistimula l-iżvilupp tal-follikuli multipli fi programmi ta' riproduzzjoni medikament assistiti [e. fl-fertilizzazzjoni in vitro/ - trasferiment tal-embriju (ivf/et), il-gameti intra-fallopjan trasferiment (gift) u intracytoplasmic-injezzjoni ta ' l-isperma (icsi). fir-raġel:defiċjenza ta ' spermatoġenesi minħabba ipogonadiżmu ipogonadotrofiku.

Union européenne - maltais - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazole - aspergillosis; candidiasis; mycoses - antimikotiċi għall-użu sistemiku-derivattivi tat-triazole - voriconazole huwa aġent broad-spectrum, aġent antifungali triazole u hija indikata fl-adulti u t-tfal li għandhom sentejn u aktar kif ġej:trattament ta 'asperġillożi invażiva;it-trattament ta'candidaemia f'pazjenti mhux newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji candida reżistenti (inkluż c. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn scedosporium spp. u fusarium spp. voriconazole għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet.

Union européenne - maltais - EMA (European Medicines Agency)

amgen europe b.v. - panitumumab - neoplażmi kolorettali - aġenti antineoplastiċi - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri. , fil-tieni linja f'kombinazzjoni ma ' folfiri għall-pazjenti li rċevew l-ewwel linja bbażata fuq fluoropyrimidine-kimoterapija (esklużi l-irinotecan). , bħala monoterapija wara falliment ta 'l-fluworopirimidina, oxaliplatin u irinotecan-korsijiet ta' kimoterapija li fiha.

Union européenne - maltais - EMA (European Medicines Agency)

pfizer europe ma eeig - gemtuzumab ozogamicin - lewkimja, mijelojda, akuta - aġenti antineoplastiċi - mylotarg huwa indikat għal terapija kkombinata b'daunorubicin (dnr) u cytarabine (arac) għall-kura ta ' pazjenti età 15-il sena u aktar li ma ġietx ikkurata qabel, de novo cd33 pożittivi għall-lewkimja majelojde akuta (aml), ħlief-lewkimja promijeloċitika akuta (apl).